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A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis
Sponsor: Immunovant Sciences GmbH
Summary
This Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult participants with active, difficult-to-treat, anti-citrullinated protein autoantibody (ACPA) positive rheumatoid arthritis (RA).
Official title: A Phase 2b, Multicenter, Double-blind, Placebo-controlled Randomized Withdrawal Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat, ACPA-Positive Rheumatoid Arthritis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-01-10
Completion Date
2027-09
Last Updated
2025-12-12
Healthy Volunteers
No
Conditions
Interventions
IMVT-1402
Administered once weekly by subcutaneous injection.
Placebo
Administered once weekly by subcutaneous injection.
Locations (83)
Site Number - 1018
Mesa, Arizona, United States
Site Number - 1019
Sun City, Arizona, United States
Site Number - 1022
Covina, California, United States
Site Number - 1028
San Leandro, California, United States
Site Number - 1024
Temecula, California, United States
Site Number - 1033
Tujunga, California, United States
Site Number - 1023
Whittier, California, United States
Site Number - 1020
Denver, Colorado, United States
Site Number - 1015
Jupiter, Florida, United States
Site Number - 1002
Miami, Florida, United States
Site Number - 1027
Plantation, Florida, United States
Site Number - 1005
Winter Park, Florida, United States
Site Number - 1012
Zephyrhills, Florida, United States
Site Number - 1001
Gainesville, Georgia, United States
Site Number - 1034
Chicago, Illinois, United States
Site Number - 1006
Cumberland, Maryland, United States
Site Number - 1007
Hagerstown, Maryland, United States
Site Number - 1031
Rockville, Maryland, United States
Site Number - 1008
Worcester, Massachusetts, United States
Site Number - 1021
Saint Clair Shores, Michigan, United States
Site Number - 1030
Kansas City, Missouri, United States
Site Number - 1010
Summit, New Jersey, United States
Site Number - 1004
Charlotte, North Carolina, United States
Site Number - 1035
Statesville, North Carolina, United States
Site Number - 1000
Duncansville, Pennsylvania, United States
Site Number - 1016
Jackson, Tennessee, United States
Site Number - 1026
Memphis, Tennessee, United States
Site Number - 1029
Murfreesboro, Tennessee, United States
Site Number - 1037
Allen, Texas, United States
Site Number - 1017
Colleyville, Texas, United States
Site Number - 1036
Katy, Texas, United States
Site Number - 1014
Mesquite, Texas, United States
Site Number - 1013
Tomball, Texas, United States
Site Number - 1025
Tomball, Texas, United States
Site Number - 5003
Buenos Aires, Argentina
Site Number - 5001
Buenos Aires, Argentina
Site Number -5004
Buenos Aires, Argentina
Site Number - 5002
Buenos Aires, Argentina
Site Number - 5005
Buenos Aires, Argentina
Site Number - 5000
San Miguel de Tucumán, Argentina
Site Number - 5603
Plovdiv, Bulgaria
Site Number - 5605
Plovdiv, Bulgaria
Site Number - 5602
Plovdiv, Bulgaria
Site Number - 5604
Rousse, Bulgaria
Site Number - 5606
Sevlievo, Bulgaria
Site Number - 5600
Sofia, Bulgaria
Site Number - 5601
Sofia, Bulgaria
Site Number - 3204
Brno, Czechia
Site Number - 3202
Ostrava, Czechia
Site Number - 3203
Praha 2 Nove Mesto, Czechia
Site Number - 3201
Uherské Hradiště, Czechia
Site Number - 3200
Zlín, Czechia
Site Number - 8000
Tbilisi, Georgia
Site Number - 8001
Tbilisi, Georgia
Site Number - 8003
Tbilisi, Georgia
Site Number - 6500
Hamburg, Germany
Site Number - 6501
Ratingen, Germany
Site Number - 7554
Budapest, Hungary
Site Number - 7555
Budapest, Hungary
Site Number - 7550
Hódmezővásárhely, Hungary
Site Number - 7553
Kecskemét, Hungary
Site Number - 7551
Székesfehérvár, Hungary
Site Number - 7552
Veszprém, Hungary
Site Number - 3005
Bialystok, Poland
Site Number - 3007
Elblag, Poland
Site Number - 3009
Lublin, Poland
Site Number - 3006
Nadarzyn, Poland
Site Number - 3008
Poznan, Poland
Site Number - 3000
Poznan, Poland
Site Number - 3003
Sochaczew, Poland
Site Number - 3004
Warsaw, Poland
Site Number - 3002
Wroclaw, Poland
Site Number - 7500
Brasov, Romania
Site Number - 7502
Bucharest, Romania
Site Number - 7501
Râmnicu Vâlcea, Romania
Site Number - 7104
Barcelona, Spain
Site Number - 7101
Bilbao, Spain
Site Number - 7102
Málaga, Spain
Site Number - 7100
Seville, Spain
Site Number - 7000
Edinburgh, United Kingdom
Site Number - 7001
London, United Kingdom
Site Number -7002
North Shields, United Kingdom
Site Number - 7003
Wolverhampton, United Kingdom